BS EN ISO 10993-18:2020+A1:2023 适用范围 范围 本文件规定了医疗器械成分识别和(如有必要)量化的框架,允许使用一般逐步的化学表征方法来识别生物危害并估计和控制材料成分的生物风险。其中可以包括以下一项或多项: — 其构造材料的标识(医疗器械配置);——通过化学成分(材料成分)的识别和定量来表征建筑材料; —...
BS EN ISO 10993-18:2009
BS EN ISO 10993-18:2020医疗器械的生物学评估 第18部分:风险管理过程中医疗器械材料的化学特性 Biological evaluation of medical devices Part 18 : Chemical characterization of medical device materials within a risk management process 被代替 2023-07
内容提示: BRITISH STANDARDBS EN ISO 10993-8:2001Biological evaluation of medical devices —Part 8: Selection and qualification of reference materials for biological testsThe European Standard EN ISO 10993-8:2001 has the status of a British StandardICS 11.040.01; 11.100NO COPYING WITHOUT BSI ...
BS EN ISO10993-1:2009ICS 11.100.20NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDBiological evaluationof medical devicesPart 1: Evaluation and testing (ISO10993-1:2003)Licensed copy: Vocational Trading Council, Vocational Training Council, Version correct as of ...
BS EN ISO 10993-16-2017 [高清版] 下载积分:1390 内容提示: 文档格式:PDF | 页数:26 | 浏览次数:143 | 上传日期:2018-12-13 23:20:53 | 文档星级: 阅读了该文档的用户还阅读了这些文档 240 p. Joker and Philosophy Why So Serious 9781394198504 283 p. Irreplaceable The Art of Standing ...
In fact,BS EN ISO 10993-10:2023is the fourth edition of this standard, which is in itself the tenth in an extensive international series on the biological evaluation of medical devices. Other standards in the series cover e.g.: animal welfare requirements, sample preparation, and good clinical...
BSI Standards PublicationBS EN ISO 10993-10:2013Biological evaluation ofmedical devicesPart 10: Tests for irritation and skinsensitization
BS EN ISO 10993-1:2020 Biological evaluation of medical devices —Part 1:Evaluation and testing within a risk management process 本文件规定: ——在风险管理过程中管理医疗器械生物学评价的一般原则; ——医疗器械根据其与身体接触的性质和持续时间的一般分类; ...
N ISO 10993-12:2012 BS EN ISO 10993-12:2012BS EN ISO 10993-12:2012